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ACTIVE SUBSTANCE / INN

BORTEZOMIB

Brand name(s): Velcade, BORTEZOMIB, Bortezomib Hospira, Bortezomib Fresenius Kabi, VELCADE, Bortezomib Accord, Bortezomib Sun
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
Multiple Myeloma
NDA208645
ACTIVE SUBSTANCE
Bortezomib
REGULATORS
FDA · EMA
SPONSORS / MAH
Janssen-Cilag International NV, MAIA PHARMS INC, TAKEDA PHARMS USA
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BORTEZOMIBANDA205533APOTEXPrescription
BORTEZOMIBNDA215331MAIA PHARMS INCDiscontinued
BORTEZOMIBNDA208645ACTAVIS LLCNone (Tentative Approval)
VELCADENDA021602TAKEDA PHARMS USAPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Bortezomib SunSUN Pharmaceutical Industries (Europe) B.V.Authorised22/07/2016Multiple Myeloma
Bortezomib AccordAccord Healthcare S.L.U.Authorised20/07/2015Multiple Myeloma
Bortezomib HospiraPfizer Europe MA EEIGAuthorised22/07/2016Multiple Myeloma
Bortezomib Fresenius KabiFresenius Kabi Deutschland GmbHAuthorised14/11/2019Multiple Myeloma
VelcadeJanssen-Cilag International NVAuthorised26/04/2004Multiple Myeloma

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